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Clinical Trials/NCT02334410
NCT02334410
Unknown
Not Applicable

Early Intervention to Reduce Bone Loss After Spinal Cord Injury

University of Strathclyde1 site in 1 country60 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
University of Strathclyde
Enrollment
60
Locations
1
Primary Endpoint
Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans
Last Updated
11 years ago

Overview

Brief Summary

After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive bone loss in the long bones of the legs. It has been documented that the most rapid phase of bone loss is during the first year, but bone loss can continue for a number of years post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous longitudinal study, in which we described rates of bone loss in the first year of SCI using peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by performing repeat bone scans within months of injury, we are able to detect and "red-flag" those patients at highest risk of rapidly weakening bones. We propose that, once these patients have been identified, there is an opportunity to intervene with bone-stimulating interventions within months of injury, before BMD reaches dangerously low values. In this new phase of the research, therefore, we are introducing an intervention phase to the longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to encourage bone formation. If shown to be successful as an early bone-stimulating intervention, it may prove to be a tool for reducing future fracture risk in patients with SCI.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
February 2018
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sylvie Coupaud

Dr

University of Strathclyde

Eligibility Criteria

Inclusion Criteria

  • Motor-complete spinal cord injury (SCI)
  • SCI at neurological levels C4 and below
  • Within six weeks of SCI

Exclusion Criteria

  • Recent bilateral fractures in tibia and/or femur
  • Previously diagnosed osteoporosis
  • Pregnancy

Outcomes

Primary Outcomes

Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans

Time Frame: 12 months

Can WBV intervention reduce the rate of bone loss in patients with early spinal cord injury?

Rate of change of calcium and bone profiles based on blood samples

Time Frame: 12 months

Biochemical markers of bone formation, bone resorption, hormone and mineral levels.

Secondary Outcomes

  • Correlation between imaging and biochemical markers of bone health(12 months)

Study Sites (1)

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